Art.Net Brain I Trial: To determine whether external counterpulsation positively affects cerebral blood flow in patients with stenotic or occluded cerebral arteries

Art.Net Brain I Trial: A prospective, randomised, controlled trial to assess the effect of external counterpulsation on cerebral hemodynamics in patients with hemodynamically relevant stenosis or occlusion of the cerebral arteries

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77215948

Enrollment

Registered

2012-07-16

Start date

2012-07-01

Completion date

Unknown

Last updated

2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ECP effects on cerebral artery stenoses Circulatory System

Interventions

The study will involve 24 patients >60 years of age with a unilateral >80% stenosis (local stenosis grade) or occlusion of the internal carotid artery, who are willing to be assigned to any of the stu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >60 years 2. Unilateral >80% stenosis (local stenosis grade) or occlusion of the internal carotid artery 3. Willing to be assigned to any of the study intervention schemes

Exclusion criteria

Exclusion criteria: 1. Contralateral stenosis of the carotid artery >70% 2. No transtemporal acoustic window for transcranial Doppler sonography, cerebral ischemic event 180 mmHg systolic, >100 mmHg diastolic) 5. Cardiac ejection fraction II° 7. Tricuspid valve insufficiency >III° 8. Aortofemoral or femoropopliteal bypass 9. Recent thrombosis of lower extremity 10. Hemorrhagic diathesis or clinical signs thereof 11. Dementia or severe cognitive disorder/mental retardation 12. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Mean cerebral blood flow velocity (CBFVmean) in the A. cerebri media ipsilateral and contralateral to the stenosis of the internal carotid artery before, during and after ECP therapy (ECP active and ECP sham)	—

Secondary

Measure	Time frame
1. CO2 reactivity (CO2normo, CO2hyper) before and after ECP active and ECP sham 2. CO2RHb, CO2RHbOx, CO2RHbRed before and after ECP active and ECP sham 3. Trans cranial Doppler envelope curve analysis (Vsystolisch max, Vdiastol. max, systolic and diastolic acceleration, PI and RI) before, during and after ECP active and ECP sham 4. Parameters of dynamic cerebral autoregulation (phase shift; spontaneous fluctuation) before, during and after ECP active and ECP sham 5. Cerebrovascular resistance before, during and after ECP active and ECP sham 6. Baro receptor reflex sensitivity before, during and after ECP active and ECP sham 7. Near infrared spectroscopy (TOI, THI, HbTot, HbOx, HbRed) before, during and after ECP active and ECP sham 8. Fow-volume analysis of the distal extracranial segment of the internal carotid artery before, during and after ECP active and ECP sham	—

Measure

Time frame

1. CO2 reactivity (CO2normo, CO2hyper) before and after ECP active and ECP sham 2. CO2RHb, CO2RHbOx, CO2RHbRed before and after ECP active and ECP sham 3. Trans cranial Doppler envelope curve analysis (Vsystolisch max, Vdiastol. max, systolic and diastolic acceleration, PI and RI) before, during and after ECP active and ECP sham 4. Parameters of dynamic cerebral autoregulation (phase shift; spontaneous fluctuation) before, during and after ECP active and ECP sham 5. Cerebrovascular resistance before, during and after ECP active and ECP sham 6. Baro receptor reflex sensitivity before, during and after ECP active and ECP sham 7. Near infrared spectroscopy (TOI, THI, HbTot, HbOx, HbRed) before, during and after ECP active and ECP sham 8. Fow-volume analysis of the distal extracranial segment of the internal carotid artery before, during and after ECP active and ECP sham

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026